Methods and systems for rapid retraction of a transcatheter heart valve delivery system

ABSTRACT

Methods for the rapid retraction of trans-catheter heart valve delivery systems are provided. A rapid retraction trans-catheter heart valve delivery system comprises a catheter based delivery system. The delivery system has internal mechanisms that allow for the controlled deployment of a heart valve prosthesis, as well as mechanisms that allow for quickly closing the catheter once the heart valve prosthesis has been implanted. This rapid retraction ability allows for reduced procedural durations and thus reduced risk to the patient.

CROSS-REFERENCE

The present application claims priority to U.S. Provisional PatentApplication No. 62/424,910 (Attorney Docket No. 53235-712.101), filed onNov. 21, 2016, which is herein incorporated by reference in itsentirety.

The present application is related to: U.S. Pat. No. 8,579,964 (AttorneyDocket No. 53235-703.201) filed Apr. 28, 2011; and also related to U.S.Publication Nos. 2013/0211508 (Attorney Docket No. 53235-704.201) filedNov. 16, 2012; 2014/0052237 (Attorney Docket No. 53235-705.201) filedFeb. 8, 2013; 2014/0155990 (Attorney Docket No 53235-706.201) filed May29, 2013; 2014/0257467 (Attorney Docket No. 53235-707.201) filed Mar. 3,2014; and 2014/0343669 (Attorney Docket No. 53235-708.201) filed Apr. 1,2014; the entire contents of each of which is incorporated herein byreference.

BACKGROUND OF THE INVENTION 1. Field of the Invention

Mitral regurgitation, also known as mitral insufficiency or mitralincompetence is a heart condition in which the mitral valve does notclose properly thereby resulting in abnormal leakage of blood retrogradefrom the left ventricle through the mitral valve back upstream into theleft atrium. Persistent mitral regurgitation can result in congestiveheart failure, a costly and often fatal condition. Traditional surgicalrepair of the valve generally results in a good clinical outcome butrequires open heart surgery and a lengthy and costly hospital stay alongwith an extended recovery period. More recently, minimally invasiveprocedures have been developed to deliver a prosthetic heart valvepercutaneously over a catheter through the patient's vasculature to theheart, or by using a transapical procedure to introduce the prosthesisthrough the chest wall and through the apex of the heart to thetreatment site. An exemplary prosthesis includes any of the embodimentsdescribed in U.S. Pat. No. 8,579,964, the entire contents of which areincorporated herein by reference. These prostheses and deliveryprocedures appear to be promising, but there is yet opportunity toimprove procedural outcomes by minimizing the duration of the procedure,from first contact with the delivery system by an operator to finalwithdrawal of the delivery system and wound closure in the patient.Therefore, it would be desirable to provide improved devices, systems,and methods that reduce the amount of time needed to remove the deliverysystem from the patient, improve ease of use, speed up the procedure,and reduce risk. At least some of these objectives will be met by theexemplary embodiments described herein.

2. Description of the Background Art

U.S. Pat. No. 8,579,964 discloses an exemplary prosthetic heart valveand trans-catheter delivery system, the entire contents previouslyincorporated herein by reference.

BRIEF SUMMARY

The present disclosure generally relates to medical systems, devices andmethods, and more particularly relates to prostheses and deliverysystems such as heart valve delivery systems that may be used to implanta prosthesis such as a valve, including a prosthetic mitral valve, aheart valve, or any other valve. The present disclosure emphasizesexemplary embodiments of a prosthetic mitral valve and delivery system,but one of skill in the art will appreciate that this is not intended tobe limiting.

In many embodiments, trans-catheter methods and systems of deployingprosthetic heart valves and rapid retraction of the delivery system areprovided. In certain embodiments, the delivery system comprises atrans-apical delivery system that may be used to implant a prostheticheart valve into anatomical position by way of an incision in the apexof the heart. The trans-apical delivery system may comprise a system ofcatheters that may be concentrically nested upon one another and that,when combined, may retain a compressed heart valve prosthesis. Removalof the constraint provided by certain catheters may then facilitatedeployment of the heart valve prosthesis into the heart. Furtherembodiments of the trans-apical delivery system that may be used in anyof the delivery systems disclose herein may allow for the closure of thedelivery catheters at an enhanced speed, such as by way of translationof catheter components within each other in the opposite direction tothat required for deployment operation. The operation of such deliverysystems may be facilitated through the use of actuator mechanisms suchas button mechanisms that may be in communication with linkage systems,or actuator mechanisms such as button mechanisms that may be incommunication with flexible members, or even pin coupled components thatsimplify use.

Further embodiments herein may include delivery systems that allow foralternative implantation pathways such as through the inferior orsuperior vena cava, the aorta, or the atria.

In an aspect of the present disclosure, a method of rapidly retracting adelivery system comprises providing a delivery system, the deliverysystem having a plurality of catheters used to deliver a heart valveprosthesis, providing a controllable deployment mechanism, thecontrollable deployment mechanism having the ability to preferentiallyrelease a prosthesis from the catheter, and actuating the controllabledeployment mechanism thereby releasing the prosthesis from the catheter.The method may also comprise providing a rapid retraction mechanism, therapid retraction mechanism having the ability to rapidly close thecatheter, actuating the rapid retracting mechanism thereby rapidlyclosing the catheter.

The method may comprise trans-apically introducing the delivery systeminto an apex of a heart, or transseptally delivering the delivery systemto a heart, delivering the delivery system to the heart via a subclavianvein, delivering the delivery system to the heart via an aorta, ordelivering the delivery system to the heart via a left atrium or a rightatrium.

Actuating the rapid retraction mechanism may comprise actuating a buttonand linkage. The rapid retraction mechanism may comprise a threadedregion and interference member, and the method may further compriseconstraining movement of the rapid retraction mechanism with thethreaded region and interference member. The rapid retraction mechanismmay comprise a flexible interference member, and the method may furthercomprise deflecting the flexible interference member. The rapidretraction mechanism may comprise a pin and pin-hole link assembly, andthe method may comprise removing the pin from the pin-hole linkassembly.

In another aspect of the present disclosure, a delivery device fordelivering a prosthesis comprises a first actuation mechanism forcontrolling movement of a delivery catheter, wherein the deliverycatheter may be configured to carry a prosthesis therein, and whereinactuation of the first actuation mechanism may move the deliverycatheter away from the prosthesis thereby at least partially removing aconstraint therefrom, and a deployment mechanism for controlling releaseof the prosthesis from an anchoring catheter, the anchoring catheterdisposed at least partially in the delivery catheter, and whereinactuation of the deployment mechanism may move the anchoring catheteraway from the prosthesis thereby releasing a constraint therefrom. Thedelivery system may also comprise an inner guidewire catheter having atapered distal tip, the inner guidewire catheter disposed in theanchoring catheter, and a rapid retraction mechanism for controllingmovement of the delivery catheter relative to the tapered distal tip,wherein actuation of the rapid retraction mechanism closes the deliverydevice such that a proximal end of the distal tip abuts against a distalend of the delivery catheter thereby forming a smooth continuous outersurface of the delivery device.

The actuation mechanism may comprise a thumbwheel. The deploymentmechanism may comprise an actuatable button with a linkage coupledthereto. The rapid retraction mechanism may comprise a threaded regionand interference member, a flexible interference member, or a pin andpin-hole linkage assembly.

In another aspect of the present disclosure, a system for delivering aprosthesis comprise the delivery device described above and a prosthesissuch as a prosthetic mitral valve.

These and other embodiments are described in further detail in thefollowing description related to the appended drawing figures.

INCORPORATION BY REFERENCE

All publications, patents, and patent applications mentioned in thisspecification are herein incorporated by reference to the same extent asif each individual publication, patent, or patent application wasspecifically and individually indicated to be incorporated by reference.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the present disclosure are set forth withparticularity in the appended claims. A better understanding of thefeatures and advantages of the present disclosure will be obtained byreference to the following detailed description that sets forthillustrative embodiments, in which the principles of the presentdisclosure are utilized, and the accompanying drawings of which:

FIG. 1 shows a perspective view of a trans-apical delivery systemconfigured to allow for rapid retraction.

FIGS. 2A-2E illustrate schematic side views of an operational sequenceof a trans-apical delivery system configured to allow for rapidretraction.

FIGS. 3A-3D illustrate partial cross-sectional breakout views of anoperational sequence of a trans-apical delivery system configured toallow for rapid retraction.

FIGS. 4A-4B illustrate isometric partial cross-sectional breakout viewsof a sequence of action of an internal mechanism within a trans-apicaldelivery system configured to allow for rapid retraction.

FIG. 5 illustrates an exploded view and internal components of atrans-apical delivery system configured to allow for rapid retraction.

FIGS. 6A-6E illustrate schematic side views of an operational sequenceof an alternate embodiment of a trans-apical delivery system configuredto allow for rapid retraction.

FIGS. 7A-7D illustrate schematic side views of an operational sequenceof another alternate embodiment of a trans-apical delivery systemconfigured to allow for rapid retraction.

FIG. 8 illustrates a schematic diagram of an exemplary prosthesis

FIGS. 9A-9B illustrate exemplary cross-sections of the prosthesis inFIG. 8.

FIGS. 10A-10B illustrate a prosthesis coupled to a delivery catheter.

FIG. 11 illustrates basic human heart anatomy.

FIGS. 12A-12C illustrate exemplary delivery methods.

FIGS. 13A-13C illustrate an exemplary method of deploying a prosthesisin the heart.

DETAILED DESCRIPTION

In the following detailed description, reference is made to theaccompanying figures, which form a part hereof In the figures, similarsymbols typically identify similar components, unless context dictatesotherwise. The illustrative embodiments described in the detaileddescription, figures, and claims are not meant to be limiting. Otherembodiments may be utilized, and other changes may be made, withoutdeparting from the scope of the subject matter presented herein. It willbe readily understood that the aspects of the present disclosure, asgenerally described herein, and illustrated in the figures, can bearranged, substituted, combined, separated, and designed in a widevariety of different configurations, all of which are explicitlycontemplated herein.

Although certain embodiments and examples are disclosed below, inventivesubject matter extends beyond the specifically disclosed embodiments toother alternative embodiments and/or uses, and to modifications andequivalents thereof. Thus, the scope of the claims appended hereto isnot limited by any of the particular embodiments described below. Forexample, in any method or process disclosed herein, the acts oroperations of the method or process may be performed in any suitablesequence and are not necessarily limited to any particular disclosedsequence. Various operations may be described as multiple discreteoperations in turn, in a manner that may be helpful in understandingcertain embodiments, however, the order of description should not beconstrued to imply that these operations are order dependent.Additionally, the structures, systems, and/or devices described hereinmay be embodied as integrated components or as separate components.

For purposes of comparing various embodiments, certain aspects andadvantages of these embodiments are described. Not necessarily all suchaspects or advantages are achieved by any particular embodiment. Thus,for example, various embodiments may be carried out in a manner thatachieves or optimizes one advantage or group of advantages as taughtherein without necessarily achieving other aspects or advantages as mayalso be taught or suggested herein.

FIG. 1 shows a perspective view of a trans-apical delivery system 1which may be configured to allow for delivery of a prosthesis such as aprosthetic heart valve with rapid retraction of the delivery systemafter the prosthesis has been delivered, whereby rapid retraction hereinmay comprise the expedient removal of the delivery catheter 8 anddilating tip 9 from the apex of a patient's heart (not shown) or othertreatment region of the patient. The trans-apical delivery system 1 maybe comprised of a dilating tapered tip 9 which is delivered directlyinto the apex of a patient's heart (not shown), a delivery catheter 8(sometimes referred to as a sheath catheter), a handle assemblyincluding a distal handle 3, a proximal external handle 2, and anactuator mechanism such as a thumbwheel 4 therebetween which may beconfigured to actuate said delivery catheter 8 in order to cause it toslidably translate away from the dilating tip 9 into an openconfiguration or open position. When the trans-apical delivery system isin the open position, a space for a prosthetic heart valve 11 or anyother prosthesis may be defined between the dilating tip 9 and thedistal edge of the delivery catheter 8 (best seen in FIG. 2A). Aninnermost lumen can be defined between the guidewire lumen inlet 13,located at the distal most end of the dilating tip 9, and the guidewirelumen outlet 14 which may be located within a connector such as a needlehub 12 having a Luer connector at its proximal end, at the proximal mostportion of the proximal external handle 2. The guidewire lumen mayextend through the guidewire catheter (sometimes also referred to as thedilator catheter) which may be axially and concentrically disposed underthe other catheters including bell catheter 10. The guidewire cathetermay be referred to as a guidewire catheter. Any of the featuresdescribing the delivery catheter 8 may be applied to any of the deliverycatheter embodiments disclosed herein. Similarly, any of the prostheticheart valve features described for prosthetic heart valve may apply tothe prostheses disclosed herein.

Also shown in FIG. 1 is an embodiment of an actuation mechanism 5, whichcan allow a user to control the final release of a prosthesis such as aprosthetic heart valve from the delivery system, and can enable furthermechanical actions that will be described below. The actuation mechanism5 may be comprised of any actuator such as a button 6, and a disposed ina housing 7 which describes a space wherein the button 6 may translate.The mechanical details behind the translation will be further describedbelow.

Turning now to FIG. 2A-2E, an operational sequence of a trans-apicaldelivery system 1 configured to allow for rapid retraction is presented.FIG. 2A shows the delivery system 1 in the closed configuration whereall catheters may be concentrically disposed over one another, and thedistal leading edge 22 of delivery catheter 8 may be disposed againstthe proximal end of dilating tip 9 to form a smooth continuous outersurface. A prosthesis such as a prosthetic heart valve may be loaded anddisposed in the space 11 and constrained by the catheters. The closedconfiguration may be configured for trans-apical delivery of theprosthesis to the treatment region in the heart. FIG. 2B shows an arrowindicating translation 20 of the distal leading edge of the deliverycatheter 22 in the proximal direction. An arrow indicating rotation 15of the thumbwheel 4 is also shown, and when the thumbwheel 4 is rotated,proximal translation of the distal leading edge of the delivery catheter8 may occur by way of internal component mechanical relationships, suchas those described within U.S. Pat. No. 8,579,964 (also referred toherein as the '964 patent), which is incorporated herein by reference.For example, FIGS. 11-15C of the '964 patent describe one exemplaryembodiment of a delivery system having features which may apply to thepresent exemplary embodiment, and FIGS. 16-20 of the '964 patentdescribe another exemplary embodiment having features which may apply tothe present exemplary embodiment. Rotation of the thumbwheel in theopposite direction may move the delivery catheter 8 in the oppositedirection, distally.

FIG. 2C shows an arrow indicating radially inward translation 16 of anactuator, here a button 6. An arrow indicating proximal translation 21of the distal leading edge 22 of the delivery catheter 8 is also shown,and also when the button 6 is depressed radially inwardly, the leadingedge of the bell catheter 10 may translate proximally away from and offof an anchoring catheter (sometimes referred as a hub catheter),anchoring tip 23, as further described in the '964 patent, for example,in FIGS. 16-20. By releasing the leading edge of the bell catheter 10(similarly referred to as a bell catheter) from the anchoring catheteranchoring tip 23, a prosthesis such as a prosthetic heart valve (notshown) may be preferentially released. The internal mechanics of thiscomponent relationship will be further described in detail below.

FIG. 2D depicts the operation of the rapid retraction functionality ofthe herein disclosed trans-apical delivery system 1. By maintainingpressure on the button 6, the proximal external handle 2 may be rotatedas depicted by the arrow indicating rotation 17. By rotating theproximal external handle 2 for one 360° rotation in a first direction(clockwise with respect to the operator), the handle can becomedisengaged from the middle section of the internal handle 24 and thusmay be free to translate proximally over internal handle 24, as depictedby the arrow indicating translation 18 (FIG. 2E). The dilator tip 9 byway of the connector such as needle hub 12 (FIG. 5), and anchoringcatheter 50 (FIG. 5) by way of the externally threaded portion ofanchoring catheter 51 (FIG. 5) may be mated to the proximal externalhandle 2. The bell catheter proximal end 68 (FIG. 5) may be fastened tothe catheter carriage 30 (FIG. 5), which may be translated along withthe proximal external handle 2, and depicted by an arrow indicatingtranslation 19 (FIG. 2E). This movement may allow the proximal end ofthe dilator tip to butt up against the distal end of the deliverycatheter 8 to form a smooth continuous surface when the delivery systemis in a closed configuration.

FIGS. 3A-3D more clearly illustrate some of the actuation mechanism.Turning now to FIG. 3A, there is illustrated the first view of asequence of views of an operational sequence of a trans-apical deliverysystem that is configured to allow for rapid retraction of the deliverysystem 1, depicted by way of cross-sectional breakout. The middlesection of the internal handle 24 is shown, which acts as a supportstructure for the proximal external handle 2 to slide thereover.Specifically, an internal circular rib 25 may traverse the distal-mostportion of the inner diameter of the proximal external handle 2, and inconjunction with the external threads 27 of the middle section of theinternal handle 24 as well as an external circular flange 42, mayprovide support and location for the middle section of the internalhandle 24 to translate within the proximal external handle 2 (shown inFIG. 5). In operable communication with the external threads 27 of themiddle section of the internal handle 24 may be internal threads 28 ofthe proximal external handle 2, which can allow for relative rotationand controlled translation between the two handles without binding orcocking, prior to disengagement. An additional feature of embodiments ofthis device which may be used in any embodiment of a delivery systemdisclosed herein, with specific regards to the external threads 27 ofthe middle section of the internal handle 24 is an internal slot 40(FIG. 4A), the details of which will be described further below.

As previously described, a button 6 may be provided which when pushed asdepicted by the arrow indicating translation 16 of the button 6, maytransmit force and motion along the shaft of the button 6, and through alinkage arm 31, thereby applying it to the catheter carriage 30 andcausing it to translate proximally, as depicted by the arrow indicatingtranslation 43 of the catheter carriage 30. Directional control of thetranslation of the button 6 may be provided by the button housing 7,which may be cylindrically shaped and acts as a piston chamber to guidethe similarly cylindrically shaped, piston-like button 6. Functionally,the combination of button 6, linkage arm 31 and catheter carriage 30 maybehave as a mechanical linkage. The transmission of force and motionbetween these components can be achieved through pin-and-hole connectionof each successive component to the next; whereas a plurality of buttonpins 46 (FIG. 5) on one end of the button 6 may be concentrically matedwith the distal pin-holes 32 of the linkage arm 31, and a plurality ofcatheter carriage pins 47 (FIG. 5) on one end of the catheter carriage30 may be concentrically mated with the proximal pin-holes 33 of thelinkage arm 31. The catheter carriage 30 has several characteristicsthat may assist in its ability to translate smoothly without binding orcocking within the proximal external handle 2. For example, the cathetercarriage 30 may have a plurality of support bosses 36 (best seen in FIG.4A) that can allow the carriage to slide within the proximal externalhandle 2 by contacting the inner surface of said proximal externalhandle 2. The catheter carriage 30 may also have a plurality of supportfins 35 that can also assist the sliding of the carriage within theproximal external handle 2 by contacting the inner surface of saidproximal external handle 2. Additionally, the plurality of support fins35 may also provide locations for the plurality of catheter carriagepins 47 (FIG. 5).

In order to provide the necessary return force for appropriatevalve-capturing ability through the distal end of the bell catheter 10,a cylindrical retaining nut 38 may be in contact with both the cathetercarriage 30 and a compression spring 39. This compression spring 39 canact to push the catheter carriage 30 and bell catheter 10 proximal end68 and distal end towards the dilating tip 9 when the button is releaseddue to the bias provided by the compression spring 39 causing the bellcatheter distal end 10 to slide over top of the anchoring catheteranchoring tip 23.

Continuing on through the sequence of views of an operational sequenceof a trans-apical delivery system that is configured to allow for rapidretraction of the delivery system 1, by turning to FIG. 3B it is shownthat further rotation of the proximal external handle 2 as depicted bythe arrow indicating rotation 17, may allow the external threads 27 ofthe middle section of the internal handle 24 and internal threads 28 ofthe proximal external handle 2 to further become disengaged. If thisrotation is continued (arrow indicating continued rotation 41 of theproximal external handle 2, FIG. 3C), the above mentioned threads mayeventually completely disengage, as illustrated in FIG. 3D. Once theabove mentioned threads are completely disengaged, the proximal externalhandle 2 may be free to translate away from the distal handle 3 whenpulled proximally by an operator, as depicted by the arrow indicatingtranslation 18 of the proximal external handle 2. The proximal end ofthe dilator tip may now be butted up against the distal end of thedelivery catheter 8 forming a smooth continuous outer surface, and allcatheters may be nested within one another. This can complete the rapidretraction process, whereupon the device can safely be removed from theapex of a patient's heart (not shown) or another treatment site. Itshould be noted that the internal circular rib 25 located on the distalend of the proximal external handle 2 may acts as a rigid, physical stopupon contact with the external circular flange 42 located at theproximal end of the middle section 24 of the internal handle. Thislimits the translation of the proximal external handle 2 and associatedcomponents relative to the internal handle, ensuring the handles do notbecome fully detached from one another.

As mentioned previously, there is an internal slot 40 (FIG. 4A) locatedat the proximal-most end of the middle section of the internal handle24. The purpose of this internal slot 40 is to provide space wherein arectangular tab 34 of the linkage arm 31 may be placed to preventunwanted rotation of the proximal external handle 2 relative to theinner handle 24 or distal handle 3, and the relationships between thesecomponents is more easily appreciated when witnessed as depicted in FIG.4A. The rectangular tab may be biased to rest in the slot when thebutton remains undepressed. One further feature of the mechanicallinkage defined by the button 6, linkage arm 31 and catheter carriage 30that must be appreciated may be realized by the pressing of the button6, whereupon the rectangular tab 34 of the linkage arm 31 becomes fullyremoved from the internal slot 40, and full rotation of the proximalexternal handle 2 relative to the inner handle 24 is thus enabled.

Turning now to FIG. 5, there is illustrated an exploded view withinternal components of a trans-apical delivery system configured toallow for rapid retraction of delivery system 1. While many of theelements of FIG. 5 have been previously described herein, additionaldetail will now be given with emphasis to certain elements used toanchor components within the handle. The proximal external handle 2 maybe comprised of two handle halves, specifically an upper section 44 anda lower section 45 which may be fastened together by way of commonlyused medical device adhesives such as cyanoacrylate UV cure adhesivesthat may be applied to a plurality of pegs 58 for mating of saidproximal external handle sections 44, 45. Other means for coupling thetwo handle halves together include but are not limited to press fits,screws, ultrasonic welding, etc. The pegs 58 are illustrated as beinglocated within the lower section 45 of the proximal external handle 2,and each peg may have a complementary boss having an aperture into whichit fits in the upper section 44, although it is not shown. The relativepositions of the pegs and bosses may be transposed. At the proximal-mostend of each of the sections (upper 44, and lower 45) of the proximalexternal handle 2 there is illustrated a plurality of rectangular slots60 that may act to securely locate and retain the body 59 of theconnector such as needle hub 12. Additionally, a plurality of pockets 56for retaining the needle hub flange 57 may be provided in closeproximity to the plurality of rectangular slots 60, in order to retainand locate a specific fastening feature of the needle hub 12, beingprimarily the needle hub flange 57. Also found within the upper section44 and lower section 45 of the proximal external handle 2 may be aplurality of rectangular pockets 55, which serve to locate and retainthe anchoring nut 48 and also provide location for an adhesive bond thatsecures the anchoring nut into the handle sections. It will beremembered that the anchoring nut 48 may provide mechanical fasteningand location of the anchoring catheter 50 by way of an externallythreaded portion 51 on the anchoring catheter 50 and an internallythreaded portion 52 within the anchoring nut 48.

FIGS. 6A-6E provide illustration of an operational sequence of analternate embodiment of a trans-apical delivery system 1 configured toallow for rapid retraction. FIG. 6A depicts the first view of anoperational sequence, showing another embodiment of a proximal externalhandle 65. In this embodiment of a proximal external handle 65, rapidretraction may be provided by way of a similar fashion as previouslydescribed herein, but with alternative means for disengagement of theproximal external handle 65 from another embodiment of a distal handlesection 66. Specifically, the actuator mechanism in this embodiment mayinclude latching buttons 49 (FIG. 6A-6C) which may be used to maintainthis embodiment of the distal handle section 66 coupled to thisembodiment of the proximal external handle 65. The latching buttons 49may be in continuous and flexible connection with this embodiment of thedistal handle section 66, but may be typically located within a recessof the proximal external handle embodiment 65. Thus, an interfering edge63 of the latching buttons may be registered against another interferingedge 62 that is within the proximal external handle embodiment 65, priorto engagement. As depicted in FIG. 6D, once both the latching buttons 49are depressed (illustrated by arrows 61 indicating translation/bendingof the cantilevered latching buttons 49) the interfering edge 63 of thebuttons may achieve clearance of the interfering edge 62 of the proximalexternal handle 65 by bending flexion (FIG. 6E). Clearance between thecomponents may allow for translation of this embodiment of the proximalexternal handle 65 away from this embodiment of the distal handle 66, asdepicted by directional arrow 67 indicating translation of the proximalexternal handle embodiment 65 (FIG. 6E). The remaining internal andexternal elements of this embodiment (FIG. 6A-6E) of a trans-apicaldelivery system 1 may be configured to allow for rapid-retraction are asthat of the delivery system described in the '964 patent.

FIGS. 7A-7D provide illustration of an operational sequence of yetanother alternate embodiment of a trans-apical delivery system 1configured to allow for rapid retraction. FIG. 7A depicts the first viewof an operational sequence, showing yet another embodiment of a proximalexternal handle 72. In this embodiment of a proximal external handle 72,rapid retraction may be provided by way of a similar fashion aspreviously described herein, but with alternative means fordisengagement of the proximal external handle 72 from yet anotherembodiment of a distal handle section 73. In the embodiment illustratedin FIG. 7A, a retaining pin/latch style of handle retention similar towhat may be seen in the modern hand-grenade may be provided.Specifically, a retaining pin 71 which may be comprised of apreferential shaped wire-form having a grasping portion 76 and shafts 75(FIG. 7C) may be used to pin a proximal external handle sectionembodiment 72 to a distal handle embodiment 73 by disposing the shafts75 in receiving pin holes 77 (located on the proximal end of the distalhandle embodiment 73) and pin holes 78 (located on the proximal handleembodiment 72). A recess 74 (FIG. 7B) in the handle for the retainingpin 71 may provide a location for the pin to sit flush with the outersurface of the proximal handle embodiment 72, preventing the snagging ofsterile gloves that may be adorned by the clinical user (not shown).Operation of the actuation mechanism here having a retaining pin 71 maybe as follows: after final deployment of a prosthetic heart valve (notshown) by sustained rotation of the thumbwheel 4 (FIG. 7B), the user maythen grasp the retaining pin 71 and pull it out of the recess 74 asdepicted by directional arrow 69 indicating translation of the retainingpin 71. Once the retaining pin shafts 75 are entirely removed from thepin holes 77, 78, the proximal external handle embodiment 72 may becomefree to translate away from the distal handle embodiment 73 as depictedby directional arrow 70 indicating translation of the proximal externalhandle embodiment 72. The remaining internal and external elements ofthis embodiment (FIG. 7A-7D) of a trans-apical delivery system 1 may beconfigured to allow for rapid-retraction are as that of the deliverysystem described in '964 patent.

Prosthesis

FIG. 8 illustrates a schematic diagram of an exemplary prosthesis 802which may be used with any of the delivery catheters disclosed herein.The prosthesis 802 is preferably a prosthetic valve such as a prostheticmitral valve, although it may be a prosthetic valve for any other regionin the body such as a prosthetic triscuspid valve, a prosthetic aorticvalve, or a prosthetic pulmonary valve. Or it may be a prosthetic venousvalve, or any other prosthetic valve, or prosthetic device. Theprostheses 802 preferably includes an expandable frame 804 with aprosthetic valve mechanism 806 and preferably includes an anchormechanism 808. The expandable frame may be balloon expandable orself-expanding and the frame expands into engagement with the nativevalve. The prosthetic valve mechanism 806 may include one, two, three,or more prosthetic valve leaflets which have an open position whichallows antegrade fluid flow therepast, and a closed configuration wherethe prosthetic valve leaflets coapt with one another to prevent orminimize retrograde fluid flow therepast. The fluid may be blood oranother body fluid. The prosthetic leaflets may be pericardial tissue orother tissues, or they may be formed from synthetic materials such aspolymers or metals. The anchor mechanism may be any structure configuredto help enagage tissue and anchor the prosthesis with the native valve.

FIGS. 9A-9B illustrates taken along the line A-A in FIG. 8 and showpossible cross-sections of the frame 804. FIG. 9A shows that theprosthesis may have a circular cross-section, and in preferredembodiments, preferably for the mitral valve, the prosthesis may have aD-shaped cross-section so that the prosthesis conforms to the nativeanatomy. Additional details about exemplary embodiments of a prosthesisare disclosed in the '964 patent previously incorporated herein byreference.

FIGS. 10A-10B illustrate a prosthesis 1008 such as the one described inFIG. 8 coupled to a delivery catheter 1002. In FIG. 10A, the prosthesisis in a collapsed configuration and being carried and constrained by thedelivery catheter 1002. The delivery catheter 1002 may be any of thedelivery catheters described herein. An outer sheath 1004 constrains theprosthesis 1008 and keeps it in the collapsed configuration and disposedover an inner shaft 1006 slidably disposed in the outer sheath 1004. Theinner shaft 1006 may be any of the inner shafts disclosed hereinincluding the bell catheter previously disclosed. Other optional shaftsin the delivery catheter are not illustrated for convenience. As theouter sheath 1004 is retracted proximally, or the bell catheter isadvanced distally, the prosthesis becomes unconstrained from the outersheath and begins to self-expand as seen in FIG. 10B. Once theprosthesis is completely unconstrained, is self-expands into position,preferably into engagement with a native valve.

Delivery

FIG. 11 illustrates basic human heart anatomy. The heart includes fourchambers, the right atrium RA, the right ventricle RV, the left atriumLA, and the left ventricle LV. Several valves prevent retrograde bloodflow. The tricuspid valve TV controls flow from the right atrium to theright ventricle, and the pulmonary valve PV controls flow out of theright ventricle RV. The mitral valve MV controls flow between the leftatrium LA and the left ventricle LV, and the aortic valve AOV controlsflow out of the aorta AO. The major vessels coupled to the heart includethe vena cava VC which brings venous blood back to the right atrium RA,and the pulmonary artery brings blood from the right ventricle RV to thelungs (not illustrated). Oxygenated blood from the lungs returns to theleft atrium LA via the pulmonary veins PVE, and blood is delivered outof the left ventricle LV to the body by the aorta AO.

FIG. 12A illustrates one exemplary delivery method for treating mitralvalve MV. In this embodiment, the delivery catheter C which may be anyof the delivery devices disclosed herein and may have any of theprostheses disclosed herein is advanced typically from a femoral vein inthe groin up into the vena cava VC into the right atrium RA and thentransseptally across the atrial septal wall into the left atrium LA andthen downward into disposition across or adjacent the native mitralvalve MV where the prosthesis may be deployed as described herein.

FIG. 12B illustrates another exemplary delivery method for treating amitral valve MV. In this embodiment, the delivery catheter C which maybe any of the delivery devices disclosed herein and may have any of theprostheses disclosed herein is advanced typically from a femoral arteryor other artery (e.g. radial artery) up into the aorta AO in to the leftventricle LV and then across the mitral valve MV or adjacent thereto fordeployment of the prosthesis as described herein.

FIG. 12C illustrates another exemplary delivery method for treating amitral valve MV. In this embodiment, the delivery catheter C which maybe any of the delivery devices described herein and may have any of theprostheses disclosed herein is typically advanced transapically fromoutside the body, through the chest well, into the apex of the heartinto the left ventricle LV and then adjacent or across the mitral valveMV where the prosthesis is then deployed as disclosed herein.

FIGS. 13A-13C illustrate an exemplary method of deploying a prosthesis Pin the heart using a delivery catheter C which may be any of thedelivery devices disclosed herein. The prosthesis is preferably a mitralvalve prosthesis but may be any of the prostheses disclosed herein. InFIG. 13A, the delivery catheter is preferably delivered transapically tothe mitral valve MV. In FIG. 13B, once the prosthesis P has beenproperly positioned relative to the native mitral valve MV, the outersheath is retracted proximally (or the inner bell shaft is advanceddistally) so that the prosthesis is unconstrained and allowed toself-expand into engagement with the native mitral valve and anchor intoposition. After the prosthetic valve has been deployed and properlypositioned and anchored, the delivery catheter is then retractedproximally and removed from the heart as seen in FIG. 13C. Theprosthetic valve now takes over the function of the native mitral valveallowing antegrade flow from the left atrium to the left ventricle andpreventing or minimizing regurgitation of blood from the left ventricleto the left atrium.

While preferred embodiments of the present invention have been shown anddescribed herein, it will be obvious to those skilled in the art thatsuch embodiments are provided by way of example only. Numerousvariations, changes, and substitutions will now occur to those skilledin the art without departing from the invention. It should be understoodthat various alternatives to the embodiments of the invention describedherein may be employed in practicing the invention. It is intended thatthe following claims define the scope of the invention and that methodsand structures within the scope of these claims and their equivalents becovered thereby.

What is claimed is:
 1. A method of rapidly retracting a delivery system,the method comprising: providing a delivery system, the delivery systemhaving a plurality of catheters used to deliver a heart valveprosthesis; providing a rapid retraction mechanism operably coupled withthe delivery system, the rapid retraction mechanism configured torapidly close the delivery system; and actuating the rapid retractingmechanism thereby rapidly closing the delivery system.
 2. The method ofclaim 1, further comprising trans-apically introducing the deliverysystem into an apex of a heart.
 3. The method of claim 2, whereinactuating the rapid retraction mechanism comprises actuating a buttonand linkage.
 4. The method of claim 2, wherein the rapid retractionmechanism comprises a screw thread and interference member, and whereinthe method further comprises constraining movement of the rapidretraction mechanism with the screw thread and interference member. 5.The method of claim 2, wherein the rapid retraction mechanism comprisesa flexible interference member, the method further comprising deflectingthe flexible interference member.
 6. The method of claim 2, wherein therapid retraction mechanism comprises a pin and pin-hole link assembly,the method further comprising removing the pin from the pin-hole linkassembly.
 7. The method of claim 1, further comprising trans-septallydelivering the delivery system to a heart.
 8. The method of claim 7,wherein actuating the rapid retraction mechanism comprises actuating abutton and linkage.
 9. The method of claim 7, wherein the rapidretraction mechanism comprises a screw and interference member, andwherein the method further comprises constraining movement of the rapidretraction mechanism with the screw and interference member.
 10. Themethod of claim 7, wherein the rapid retraction mechanism comprises aflexible interference member, the method further comprising deflectingthe flexible interference member.
 11. The method of claim 7, wherein therapid retraction mechanism comprises a pin and pin-hole link assembly,the method further comprising removing the pin from the pin-hole linkassembly.
 12. The method of claim 1, further comprising delivering thedelivery system to the heart via a subclavian vein.
 13. The method ofclaim 12, wherein actuating the rapid retraction mechanism comprisesactuating a button and linkage.
 14. The method of claim 12, wherein therapid retraction mechanism comprises a screw thread and interferencemember, and wherein the method further comprises constraining movementof the rapid retraction mechanism with the screw thread and interferencemember.
 15. The method of claim 12, wherein the rapid retractionmechanism comprises a flexible interference member, the method furthercomprising deflecting the flexible interference member.
 16. The methodof claim 12, wherein the rapid retraction mechanism comprises a pin andpin-hole linkage assembly, the method further comprising removing thepin from the pin-hole linkage assembly.
 17. The method of claim 1,further comprising delivering the delivery system to the heart via anaorta.
 18. The method of claim 17, wherein actuating the rapidretraction mechanism comprises actuating a button and linkage.
 19. Themethod of claim 17, wherein the rapid retraction mechanism comprises ascrew thread and interference member, the method further comprisingconstraining movement of the rapid retraction mechanism with the screwthread and interference member.
 20. The method of claim 17, wherein therapid retraction mechanism comprises a flexible interference member, themethod further comprising deflecting the flexible interference member.21. The method of claim 17, wherein the rapid retraction mechanism iscomprised of a pin and pin-hole linkage assembly, the method furthercomprising removing the pin from the pin-hole linkage assembly.
 22. Themethod of claim 1, further comprising delivering the delivery system toa heart via a right atrium or via a left atrium.
 23. The method of claim22, wherein actuating the rapid retraction mechanism comprises actuatinga button and linkage.
 24. The method of claim 22, wherein the rapidretraction mechanism comprises a screw thread and interference member,the method further comprising constraining movement of the rapidretraction mechanism with the screw thread and interference member. 25.The method of claim 22, wherein the rapid retraction mechanism comprisesa flexible interference member, the method further comprising deflectingthe flexible interference member.
 26. The method of claim 22, whereinthe rapid retraction mechanism comprises a pin and pin-hole linkageassembly, the method further comprising removing the pin from thepin-hole linkage assembly.
 27. The method of claim 1, further comprisingproviding a controllable deployment mechanism, the controllabledeployment mechanism configured to preferentially release a prosthesisfrom the delivery system.
 28. The method of claim 27, further comprisingactuating the controllable deployment mechanism by rotating a thumbwheeloperably coupled with the delivery system.
 29. A delivery device fordelivering a prosthesis, said device comprising: a delivery catheterconfigured to carry a prosthesis therein; a dilator catheter disposed inthe delivery catheter, the dilator catheter having a tapered distal tipcoupled thereto; a rapid retraction mechanism for controlling movementof the delivery catheter relative to the tapered distal tip, whereinactuation of the rapid retraction mechanism closes the delivery devicesuch that a proximal end of the tapered distal tip abuts against adistal end of the delivery catheter, thereby forming a smooth continuousouter surface on the delivery device.
 30. The device of claim 29,further comprising a first actuation mechanism for controlling movementof the delivery catheter, wherein actuation of the first actuationmechanism moves the delivery catheter away from the prosthesis therebyat least partially removing a constraint therefrom.
 31. The device ofclaim 30, further comprising a deployment mechanism for controllingrelease of the prosthesis from an anchoring catheter, the anchoringcatheter disposed at least partially in the delivery catheter, andwherein actuation of the deployment mechanism moves the anchoringcatheter away from the prosthesis thereby releasing a constrainttherefrom.
 32. The device of claim 30, wherein the first actuationmechanism comprises a thumbwheel.
 33. The device of claim 30, whereinthe deployment mechanism comprises an actuatable button with a linkagecoupled thereto.
 34. The device of claim 29, wherein the rapidretraction mechanism comprises a screw thread and interference member.35. The device of claim 29, wherein the rapid retraction mechanismcomprises a flexible interference member.
 36. The device of claim 29,wherein the rapid retraction mechanism comprises a pin and pin-holelinkage assembly.
 37. A system for delivering a prosthesis, said systemcomprising: the device of claim 29; and the prosthesis.
 38. The systemof claim 37, wherein the prosthesis comprises a prosthetic mitral valve.